FDA Cautious About Expanding Use of Painkiller Fentora
Granting wider approval for the powerful cancer painkiller Fentora could lead to potentially fatal misuse of the drug, says the U.S. Food and Drug Administration, which is considering whether to approve the drug to treat pain in non-cancer patients.
An FDA advisory panel will meet Tuesday to discuss the issue and make a recommendation to the agency, the Associated Press reported.
The FDA's cautious attitude is reflected in a review of the suggested new use. Granting approval for wider use of Fentora could encourage "abuse and misuse, and increase the incidence of accidental exposures which ... could potentially have devastating effects," the agency noted.
Fentora was approved by the FDA in 2006 for treatment of cancer pain in adults who are already taking opioid drugs, which include morphine, codeine and Fentora, the AP reported. But the drug has frequently been used outside those guidelines, resulting in harmful side effects and death in some cases. Drug maker Cephalon has reported five deaths due to improper use of Fentora, the news service said.
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FDA Panel to Assess Abuse-Resistant OxyContin
A new version of the painkiller OxyContin, designed to be harder to abuse, will be evaluated Monday by a U.S. Food and Drug Administration advisory panel to determine if the reformulated version should be allowed on the market before long-term studies determine if it actually reduces abuse.
The new version has a plastic-like coating that makes it harder to crush and turns it into a gooey mess if someone tries to inject it, according to drug maker Purdue Pharma LP, the Associated Press reported.
After OxyContin was introduced in 1996, abusers quickly found they could get a heroin-like high if they snorted or injected crushed tablets.
In a letter to the advisory panel, Dr. Bob Rappaport, the FDA's chief of painkilling drugs, wrote that "there is no perfect formulation that can resist all forms of tampering." If approved, the label on the new version of OxyContin "would have to be carefully crafted so as to avoid the publication of a road map describing how to defeat these changes," he said.
An abuse-resistant gelatin-like form of the drug is being developed by two other companies, Pain Therapeutics Inc. and King Pharmaceuticals, the AP reported.
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In Vitro Fertilization Doesn't Affect Menopause: Study
Women who have in vitro fertilization (IVF) don't experience early menopause or more severe menopause symptoms, says a British study that's one of the first to examine the long-term effects of the fertility treatment.
The study included about 200 women, average age just over 50, who were among the first to undergo IVF in the 1980s. The age at which they started menopause was comparable with the national average and there was no increase in menopausal symptoms associated with the number of IVF treatments, BBC News reported.
The findings were published online in the journal Reproductive Bio Medicine.
Doctors long ago dismissed fears that stimulating the ovaries to generate eggs required for IVF treatment may speed up the ovaries' decline. This study provides needed clinical evidence, the researchers said.
The study findings weren't surprising, but it "nonetheless is a very helpful study indeed," Laurence Shaw, spokesman for the British Fertility Society, told BBC News.
"This is a question patients often ask -- and it's very useful to finally have a scientific study to point to which offers them reassurance that IVF will not affect the timing or severity of the menopause," Shaw said.
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Children's Storage Bins Recalled for Lead Hazard
About 84,000 children's storage bins sold at Lowe's stores across the United States are being recalled because they could contain excessive levels of lead, says the U.S. Consumer Product Safety Commission.
The bins are wooden with scalloped edges and were sold in pastel green or pink. Item number 226782 (pastel green bin) and item number 226781 (pink bin) is located on the bottom of the bin. They were sold from March 2007 through February 2008 for about $6.
Consumers should take the bins away from children and return the bins to any Lowe's store for a full refund, the CPSC said.
The bins were made in Taiwan and imported by LG Sourcing Inc., of North Wilkesboro, N.C.
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Psoriasis Drug Enbrel Gets Black Box Label Warning
The label of the skin disorder drug Enbrel will carry a stronger boxed warning about the risk of life-threatening infections such as tuberculosis and sepsis. Information about the bolstered warning was posted Thursday on the U.S. Food and Drug Administration Web site, and drug makers Wyeth and Amegen Inc. alerted doctors in a March 14 letter.
A black box warning is the most serious a drug can carry. Previously, the warning information appeared in bolded text, which is considered a less serious warning, the Associated Press reported.
"Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with Enbrel," the warning label states. It notes that tuberculosis was observed in two out of 20,000 patients who took part in drug company studies.
Enbrel is primarily used to treat psoriasis and sometimes used to treat rheumatoid arthritis and rare autoimmune disorders, the AP reported.
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Antidepressants May Help Treat Bowel Disorder
Antidepressants may help people with inflammatory bowel disease (IBD), say Canadian researchers who identified a link between IBD and depression, CBC News reported.
"The gut is intimately connected to the brain, more than any other organ in the body," lead researcher Jean-Eric Ghia, a post-doctoral fellow at McMaster University in Hamilton, said in a prepared statement.
In tests on depressed mice with IBD, the researchers found that the antidepressant desmethylimipramine reduced intestinal inflammation in the intestines and restored normal intestinal function. But this treatment wasn't effective in mice with no vagus nerve, which runs between the brain stem and the gastrointestinal tract, CBC News reported.
Ghia said the findings "prompt close consideration of the relationship between depression and disease activity in patients with IBD." If there is a link, "then depressed patients with IBD might be selected for novel treatment strategies" that could include antidepressants.
The study appears in the Journal of Clinical Investigation.
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